Trial Outcomes & Findings for Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID. (NCT NCT02153645)
NCT ID: NCT02153645
Last Updated: 2022-02-16
Results Overview
The Unified Dyskinesia Rating Scale is a validated tool for assessment of dyskinesia (involuntary movements) in Parkinson's Disease patients. Rating consists of the change from baseline to Day 98 of the sum of the 26 questions comprising the questionnaire. Each question in the questionnaire is rated on a 5 point scale from 0-4 where 0 is a better outcome. Questions assess: over the past week total hours with dyskinesia and total hours without dyskinesia; problems with speech, chewing and swallowing, eating, dressing, hygiene, handwriting, hobbies, balance, socializing, emotions, spasm or cramps, pain without dystonia (spasm or cramps) and pain from dystonia, the degree of impairment for each of 7 body parts, and the degree of disability in communication, drinking from a cup, dressing and ambulation. The minimum score is 0 (better) and the maximum score is 130 (worse).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
87 participants
Primary outcome timeframe
From baseline to Day 98
Results posted on
2022-02-16
Participant Flow
Participant milestones
| Measure |
240mg Amantadine Hydrochloride (HCl) ER Tablets
Amantadine HCl ER Tablets 240mg daily for 12 weeks post two week titration phase.
Amantadine ER Tablets
|
320mg Amantadine HCl ER Tablets
Amantadine HCl ER Tablets 320mg daily for 12 weeks post a two week dose titration phase.
Amantadine ER Tablets
|
Placebo Tablets for Amantadine
Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 16 weeks.
Placebo Tablets for Amantadine ER Tablets
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
28
|
|
Overall Study
COMPLETED
|
17
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
13
|
10
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID.
Baseline characteristics by cohort
| Measure |
240mg Amantadine HCl ER Tablets
n=30 Participants
Amantadine HCl ER Tablets 240mg daily for 12 weeks post two week titration phase.
Amantadine ER Tablets
|
320mg Amantadine HCl ER Tablets
n=29 Participants
Amantadine HCl ER Tablets 320mg daily for 12 weeks post a two week dose titration phase.
Amantadine ER Tablets
|
Placebo Tablets for Amantadine
n=28 Participants
Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 16 weeks.
Placebo Tablets for Amantadine ER Tablets
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
68.6 years
STANDARD_DEVIATION 8.02 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 9.17 • n=7 Participants
|
66.1 years
STANDARD_DEVIATION 8.04 • n=5 Participants
|
66.1 years
STANDARD_DEVIATION 8.61 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
16 participants
n=7 Participants
|
8 participants
n=5 Participants
|
31 participants
n=4 Participants
|
|
Region of Enrollment
France
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
10 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
8 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
16 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline to Day 98The Unified Dyskinesia Rating Scale is a validated tool for assessment of dyskinesia (involuntary movements) in Parkinson's Disease patients. Rating consists of the change from baseline to Day 98 of the sum of the 26 questions comprising the questionnaire. Each question in the questionnaire is rated on a 5 point scale from 0-4 where 0 is a better outcome. Questions assess: over the past week total hours with dyskinesia and total hours without dyskinesia; problems with speech, chewing and swallowing, eating, dressing, hygiene, handwriting, hobbies, balance, socializing, emotions, spasm or cramps, pain without dystonia (spasm or cramps) and pain from dystonia, the degree of impairment for each of 7 body parts, and the degree of disability in communication, drinking from a cup, dressing and ambulation. The minimum score is 0 (better) and the maximum score is 130 (worse).
Outcome measures
| Measure |
240 mg Amantadine HCl ER Tablets
n=30 Participants
Amantadine HCl ER Tablets 240 mg daily for 12 weeks post two week titration phase.
Amantadine ER Tablets
|
320 mg Amantadine HCl ER Tablets
n=29 Participants
Amantadine HCl ER Tablets 320 mg daily for 12 weeks post two week titration phase.
Amantadine ER Tablets
|
Placebo Amantadine HCl ER Tablets
n=28 Participants
Amantadine HCl ER Placebo Tablets daily for 12 weeks post two week titration phase.
Amantadine ER Tablets
|
|---|---|---|---|
|
Unified Dyskinesia Rating Scale
Visit 7 (Day 98)/Stable Dose LOCF [1]
|
27.5 score on a scale
Standard Deviation 19.13
|
26.4 score on a scale
Standard Deviation 13.17
|
28.7 score on a scale
Standard Deviation 13.70
|
|
Unified Dyskinesia Rating Scale
Visit 2 (Baseline)
|
46.2 score on a scale
Standard Deviation 13.19
|
39.2 score on a scale
Standard Deviation 11.91
|
38.7 score on a scale
Standard Deviation 11.23
|
|
Unified Dyskinesia Rating Scale
Change from Baseline (SD)
|
-18.8 score on a scale
Standard Deviation 16.38
|
-13.3 score on a scale
Standard Deviation 13.73
|
-9.6 score on a scale
Standard Deviation 14.87
|
SECONDARY outcome
Timeframe: Day 14 and Day 98 of treatmentPopulation: The number analyzed was the number of subjects with values at each time point.
Change from baseline in the number of awake hours without troublesome dyskinesia (involuntary movements). Every half hour the subject will indicate in the diary if the medication has ("ON") or has not ("OFF") produced benefits in terms of mobility, slowness and rigidity. Valid diaries of the 3 consecutive days prior to each visit will be averaged with respect to the number of awake hours without troublesome dyskinesia. The change from baseline in the number of waking hours that subjects report being "ON" without troublesome dyskinesias will be analyzed at analysis visits Day 14 and Day 98 of treatment. Higher scores mean a better outcome and the maximum value is 24 hours.
Outcome measures
| Measure |
240 mg Amantadine HCl ER Tablets
n=30 Participants
Amantadine HCl ER Tablets 240 mg daily for 12 weeks post two week titration phase.
Amantadine ER Tablets
|
320 mg Amantadine HCl ER Tablets
n=29 Participants
Amantadine HCl ER Tablets 320 mg daily for 12 weeks post two week titration phase.
Amantadine ER Tablets
|
Placebo Amantadine HCl ER Tablets
n=28 Participants
Amantadine HCl ER Placebo Tablets daily for 12 weeks post two week titration phase.
Amantadine ER Tablets
|
|---|---|---|---|
|
Mobility State Self-Assessment - Subject Diary Cards
Visit 2 (Baseline)
|
3.5 score on a scale
Standard Deviation 2.02
|
3.3 score on a scale
Standard Deviation 2.63
|
4.3 score on a scale
Standard Deviation 2.59
|
|
Mobility State Self-Assessment - Subject Diary Cards
Visit 7 (Day 98)/Stable Dose LOCF [1]
|
4.1 score on a scale
Standard Deviation 2.48
|
2.8 score on a scale
Standard Deviation 2.24
|
3.8 score on a scale
Standard Deviation 2.36
|
|
Mobility State Self-Assessment - Subject Diary Cards
Change from Baseline (SD)
|
0.8 score on a scale
Standard Deviation 2.92
|
-0.5 score on a scale
Standard Deviation 2.18
|
0.1 score on a scale
Standard Deviation 2.78
|
Adverse Events
240mg Amantadine HCl ER Tablets
Serious events: 3 serious events
Other events: 20 other events
Deaths: 1 deaths
320mg Amantadine HCl ER Tablets
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo Tablets for Amantadine
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
240mg Amantadine HCl ER Tablets
n=30 participants at risk
Amantadine HCl ER Tablets 240mg daily for 12 weeks post two week titration phase.
Amantadine ER Tablets
|
320mg Amantadine HCl ER Tablets
n=29 participants at risk
Amantadine HCl ER Tablets 320mg daily for 12 weeks post a two week dose titration phase.
Amantadine ER Tablets
|
Placebo Tablets for Amantadine
n=28 participants at risk
Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 16 weeks.
Placebo Tablets for Amantadine ER Tablets
|
|---|---|---|---|
|
Blood and lymphatic system disorders
syncope
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Blood and lymphatic system disorders
traumatic haemothroax
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Gastrointestinal disorders
megacolon multi-organ failure
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Musculoskeletal and connective tissue disorders
arthralgia osteonecrosis
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Psychiatric disorders
impulse-control disorder
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Cardiac disorders
arrhythmia supraventricular
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
Other adverse events
| Measure |
240mg Amantadine HCl ER Tablets
n=30 participants at risk
Amantadine HCl ER Tablets 240mg daily for 12 weeks post two week titration phase.
Amantadine ER Tablets
|
320mg Amantadine HCl ER Tablets
n=29 participants at risk
Amantadine HCl ER Tablets 320mg daily for 12 weeks post a two week dose titration phase.
Amantadine ER Tablets
|
Placebo Tablets for Amantadine
n=28 participants at risk
Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 16 weeks.
Placebo Tablets for Amantadine ER Tablets
|
|---|---|---|---|
|
Infections and infestations
Viral infection
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
1/30 • Number of events 1 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Investigations
Bacterial test positive
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Investigations
Blood glucose increased
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Investigations
Blood pressure orthostatic
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Investigations
Haemoglobin urine present
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Investigations
Neutrophil count increased
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Investigations
Protein urine present
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Investigations
Urine ketone body present
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Investigations
Urine leukocyte esterase positive
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Investigations
Weight decreased
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Investigations
White blood cell count increased
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
1/30 • Number of events 1 • Three months
|
6.9%
2/29 • Number of events 2 • Three months
|
0.00%
0/28 • Three months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.3%
1/30 • Number of events 1 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Nervous system disorders
Akinesia
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Nervous system disorders
Carpal tunnel syndorme
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • Number of events 1 • Three months
|
10.3%
3/29 • Number of events 3 • Three months
|
0.00%
0/28 • Three months
|
|
Nervous system disorders
Dyskinesia
|
10.0%
3/30 • Number of events 3 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
10.7%
3/28 • Number of events 3 • Three months
|
|
Nervous system disorders
Dystonia
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Nervous system disorders
Freezing phenomenon
|
3.3%
1/30 • Number of events 1 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Nervous system disorders
Headache
|
6.7%
2/30 • Number of events 2 • Three months
|
0.00%
0/29 • Three months
|
7.1%
2/28 • Number of events 2 • Three months
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Nervous system disorders
On and off phenomenon
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Nervous system disorders
Sciatica
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Nervous system disorders
Somnolence
|
6.7%
2/30 • Number of events 2 • Three months
|
0.00%
0/29 • Three months
|
7.1%
2/28 • Number of events 2 • Three months
|
|
Nervous system disorders
Syncope
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Nervous system disorders
Tension headache
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Nervous system disorders
Tremor
|
3.3%
1/30 • Number of events 1 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/30 • Three months
|
6.9%
2/29 • Number of events 2 • Three months
|
0.00%
0/28 • Three months
|
|
Psychiatric disorders
Confusional state
|
6.7%
2/30 • Number of events 2 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Psychiatric disorders
Depression
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/30 • Three months
|
13.8%
4/29 • Number of events 4 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Psychiatric disorders
Hallucination, visual
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Psychiatric disorders
Hypersexuality
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Psychiatric disorders
Illusion
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Psychiatric disorders
Impulse-control disorder
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Psychiatric disorders
Insomnia
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Psychiatric disorders
Nightmare
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
6.7%
2/30 • Number of events 2 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Psychiatric disorders
Sleep attacks
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Renal and urinary disorders
Pollakiuria
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Renal and urinary disorders
Renal Failure
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Renal and urinary disorders
Urinary retention
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Reproductive system and breast disorders
Prostatism
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Social circumstances
Gambling
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Vascular disorders
Hypertension
|
3.3%
1/30 • Number of events 1 • Three months
|
10.3%
3/29 • Number of events 3 • Three months
|
0.00%
0/28 • Three months
|
|
Vascular disorders
Hypotension
|
6.7%
2/30 • Number of events 2 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/30 • Three months
|
6.9%
2/29 • Number of events 2 • Three months
|
7.1%
2/28 • Number of events 2 • Three months
|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Cardiac disorders
Extrasystoles
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Eye disorders
Cataract
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Eye disorders
Diplopia
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Eye disorders
Dry Eye
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Eye disorders
Vision Blurred
|
3.3%
1/30 • Number of events 1 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 1 • Three months
|
6.9%
2/29 • Number of events 2 • Three months
|
0.00%
0/28 • Three months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Gastrointestinal disorders
Dry Mouth
|
3.3%
1/30 • Number of events 1 • Three months
|
10.3%
3/29 • Number of events 3 • Three months
|
0.00%
0/28 • Three months
|
|
Gastrointestinal disorders
Megacolon
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
7.1%
2/28 • Number of events 2 • Three months
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
General disorders
Asthenia
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
General disorders
Fatigue
|
3.3%
1/30 • Number of events 1 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
General disorders
Gait disturbance
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
General disorders
General physical health deterioration
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
General disorders
Multi-organ failure
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
General disorders
Oedema
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
General disorders
Oedema peripheral
|
6.7%
2/30 • Number of events 2 • Three months
|
13.8%
4/29 • Number of events 4 • Three months
|
0.00%
0/28 • Three months
|
|
General disorders
Peripheral swelling
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Infections and infestations
Ear infection
|
0.00%
0/30 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
0.00%
0/28 • Three months
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
1/30 • Number of events 1 • Three months
|
13.8%
4/29 • Number of events 4 • Three months
|
0.00%
0/28 • Three months
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/30 • Three months
|
0.00%
0/29 • Three months
|
3.6%
1/28 • Number of events 1 • Three months
|
|
Infections and infestations
Orchitis
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Infections and infestations
Skin infection
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Infections and infestations
Stoma site infection
|
3.3%
1/30 • Number of events 1 • Three months
|
0.00%
0/29 • Three months
|
0.00%
0/28 • Three months
|
|
Infections and infestations
Urinary tract infection
|
6.7%
2/30 • Number of events 2 • Three months
|
3.4%
1/29 • Number of events 1 • Three months
|
7.1%
2/28 • Number of events 2 • Three months
|
Additional Information
George Wagner, VP of Regulatory Affairs
Osmotica Pharmaceuticals
Phone: 908-809-1357
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator shall allow SPONSOR 60 days to review any manuscript and 30 days to review any poster presentation, abstract or any other written or oral material which discloses the Study Results. SPONSOR may request in writing an additional 60 days for review. SPONSOR may remove all Confidential Information from any publications or presentations, or if deemed not sufficient to protect its Intellectual Property Rights, then SPONSOR may embargo the publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER